The European Medicines Agency (EMA) has approved an additional subcutaneous administration option for Takhzyro (lanadelumab) to treat HAE.
The additional 2mL pre-filled pen option for Takhzyro is now approved for patients aged 12 years and above with recurrent attacks of HAE.
It will be available in a 300 mg solution for injection in a pre-filled pen, containing 300 mg of lanadelumab in 2mL of solution.
Takeda is expanding treatment options with a new subcutaneous formulation for HAE. This provides personalised care to patients, helping to reduce disease burden and improve quality of life.
In the European Union (EU), Takhzyro is authorised for the routine prevention of recurrent HAE attacks in adolescents.
It is already approved in 150 mg and 300 mg pre-filled syringes, and 300 mg vials for injection.
The latest approval was supported by results from a clinical trial.
Takeda HAE global medical lead Irmgard Andresen said: “HAE affects an estimated 1 in 50,000 people worldwide and is often under recognised, under diagnosed and under treated.
“We welcome the swift approval by the EMA on this additional subcutaneous administration option.
“HAE patients 12 years and older now have an additional individualised treatment option available to them.”
Lanadelumab is a fully human monoclonal antibody that targets plasma kallikrein. In HAE prevention studies, the drug showed a consistent reduction in attacks.
In late 2023, the European Commission approved a label expansion for lanadelumab to prevent recurrent attacks of HAE in patients aged two years and older.
This followed the February 2023 approval by the US Food and Drug Administration (FDA) for the same expanded use.
In Japan, it was approved in 2022 to treat patients aged 12 years and above.
